MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO KIT; CATHETER, CONTINUOUS FLUSH

Model Number	29460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device snapped.A renegade hi flow 105/10 kit was selected for use.During preparation, the carrier tube was hydrated before removing the device.When it was pulled out of the loop, it was found out that the catheter had been snapped and could see the braiding inside.The procedure was completed with another renegade device.No patient complications were reported.
Event or Problem Description
It was reported that the device snapped.A renegade hi flow 105/10 kit was selected for use.During preparation, the carrier tube was hydrated before removing the device.When it was pulled out of the loop, it was found out that the catheter had been snapped and could see the braiding inside.The procedure was completed with another renegade device.No patient complications were reported.Device evaluated by manufacturer: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device was fractured in 1 location.The location of the fracture was 4cm from the hub.The shaft was not completely separated the inner liner was still connected.The stretching and the fractures that were noticed on the device are consistent with the device being removed from the shipping tube without being completely hydrated with saline.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the device snapped.A renegade hi flow 105/10 kit was selected for use.During preparation, the carrier tube was hydrated before removing the device.When it was pulled out of the loop, it was found out that the catheter had been snapped and could see the braiding inside.The procedure was completed with another renegade device.No patient complications were reported.Device evaluated by manufacturer: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device was fractured in 1 location.The location of the fracture was 4cm from the hub.The shaft was not completely separated the inner liner was still connected.The stretching and the fractures that were noticed on the device are consistent with the device being removed from the shipping tube without being completely hydrated with saline.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7938922
• Report Number: 2134265-2018-61628
• Device Sequence Number: 1449634
• Product Code: KRA
• UDI-Device Identifier: 08714729280736
• UDI-Public: 08714729280736
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0022107854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1